Induction With Complement Inhibitor Eculizumab in Clinical Islet Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Increased survival of ICC´s transplanted as measured by peak c-peptide
研究概览
简要总结
This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant.
详细描述
This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant. Ten patients from 2 centres (Uppsala University Hospital and Karolinska University Hospital in Stockholm) will be transplanted. The purpose of the study is to investigate if selective complement inhibition by eculizumab combined with standard anticoagulation during and after transplantation can further reduce the extent of early tissue loss after portal infusion of islets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 to 65 years of age
- •Patients able to provide written informed consent
- •Absent stimulated c-peptide (< 0.1 nmol/L). This includes also previously islet-transplanted patients with no detectable c-peptide.
- •Patients at fear of severe hypoglycemia
- •Female patients of child bearing potential must have a negative pregnancy test (s-β-HCG) and must be practicing an effective, reliable medical accepted contraceptive regimen while on eculizumab treatment and to study end at 75 days.
- •Patients vaccinated against Neisseria meningitides or patients accepting adequate antibiotic prophylaxis
排除标准
- •Body mass index > 30 kg/m2
- •Untreated proliferative diabetes retinopathy
- •Recipient of any other concomitant organ transplantation - Glomerular filtration rate < 50 mL/min before first islet transplantation
- •Positive T-cell cross-matching by Complement Depending Cytotoxicity (CDC)
- •Pregnancy or lactating
- •Active ongoing infection, bacterial or viral
- •Unresolved meningococcal disease
- •Known bleeding disorder
- •Known complement disorder
- •Have received any other investigational drug within 30 days before inclusion
- •History of drug or alcohol abuse within the last year
研究组 & 干预措施
Eculizumab
Intravenous infusion
干预措施: Eculizumab (Drug)
结局指标
主要结局
Increased survival of ICC´s transplanted as measured by peak c-peptide
时间窗: During and within two hours post infusion (day 0).
Determined by PET-scan of 2-deoxy-27fluoro-D-glucose (18F) (FDG)-labelled islets infused in the portal vein.
次要结局
- Bleeding(From infusion until 2 hours post start of infusion)
- Estimated glomerular filtration rate (GFR) (Cystatin C)(At day 75)
- Effect of eculizumab on instant blood mediated inflammatory reaction (IBMIR) as determined by complement activation.(At the end of infusion and 1 and 2 h post start of infusion (day 0).)
- Adverse events (AEs) and serious adverse events (SAEs)(From start of infusion until 75 days post-transplant.)
- Patient and graft survival at 75 days post treatment.(From start of infusion until 75 days post-transplant.)
- Monitoring of islet-function and survival.(14, 30 and 75 days post-transplant.)
- Portal vein thrombosis(The day after infusion)